Supply chain evaluation for foot orthotic provision in the NHS

Not Applicable

Completed

• Conditions: Diabetes; Nutritional, Metabolic, Endocrine; Diabetic Foot

• Registration Number: ISRCTN10978940
• Lead Sponsor: niversity of Salford

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30636974 results (added 16/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-04
• Study Completion: 2016-11-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

1. Aged between 40 and 85 years
2. Have diabetes diagnosed by a medical practitioner
3. Have modular or bespoke (non standard) footwear provided by the orthotics department
4. Have all normal foot structures present
5. Be able to walk without a stick for 100 metres
6. Have sensory neuropathy as assessed by 10mg monofilament and vibratory perception at 3 of 10 sites on the foot and ankle
7. Have detectable pulse in foot and ankle (palpation or Doppler)
8. Must be capable of providing informed consent to participate

Exclusion Criteria

1. Have had prior foot or ankle surgery
2. Have had prior major injuries to lower limb (e.g. fractures requiring internal fixation, skin grafts)
3. Have prior or active chronic foot or leg ulceration and without episode of ulceration within last 2 years.
4. Require heel pressure reduction intervention
5. Have had prescription foot orthoses via the orthotics department in the last 12 months
6. Co-morbidities (ischemia, renal, charcot arthorpathy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plantar pressure will be measured using an in shoe plantar pressure system which captures data concerning the distribution of weight across the bottom of the foot whilst wearing the orthotic insoles at baseline, 1, 2, 5 and 8 months.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Patient outcomes measured using validated questionnaires (EQ5D, ICECAP, FHSQ) at months 0, 1, 2, 5 and 8.<br> 2. Compliance measured via telephone check-ups at months 3, 4, 5, 6, 7 and 8<br> 3. Organisational outcomes measured using service data (number of appointments, number of foot wear and orthotic products supplied) at months 0 - 8<br> 4. Service use data measured via a clinical service receipt inventory at months, 0 - 8<br>